Risperdal Tablets 1 mg (Risperidone)

Adult dose

The therapeutic dose of this medication should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. 1. Schizophrenia 1) Adults (1) Initial dose: Administer 1 mg of risperidone orally twice daily and increase the dose gradually. (2) Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose as appropriate according to age and symptoms. (3) No additional benefit was observed with doses of 10 mg or more per day compared with lower doses, and such doses may increase the risk of extrapyramidal symptoms. Doses of 10 mg or more per day should be administered only when the benefits to the individual patient are considered to outweigh the risks. (4) Do not administer doses of 16 mg or more per day, as safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Administration in special populations • Elderly patients and patients predisposed to hypotension The initial dose is 0.5 mg twice daily. Depending on the patient's condition, increase by 0.5 mg twice daily until a dose of 1～2 mg twice daily is reached. In general, increases to doses of 1.5 mg or more per administration, twice daily, should be made at intervals of at least 1 week. 3) Switching from an existing antipsychotic medication to this medication When medically appropriate, initiate this medication while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic medication, if medically appropriate, initiate this medication in place of the next scheduled depot injection. Regularly reassess whether concomitant antiparkinsonian medication needs to be continued. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg of this medication twice daily. If needed, depending on the patient, the dose may be increased by 0.25 mg per administration twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg twice daily, but the dose may be increased to 1 mg twice daily depending on the patient. Once the patient reaches the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medication should be evaluated.. 3. Adjunctive treatment of mania in bipolar disorder • The recommended initial dose is 2 mg of this medication once daily. Depending on the patient, the dose may be increased by 1 mg per day at intervals of at least 24 hours. The optimal dose for most patients is within the range of 2∼6 mg per day. As with symptomatic treatment, the appropriateness of continued use of this medication should be evaluated. Renal and hepatic impairment In patients with renal or hepatic impairment, administer half the initial and maintenance doses and adjust the dose more gradually. Exercise caution when administering this medication to these patients (see 5. General Precautions).

Child dose

Clinical experience in children and adolescents under 15 years of age is limited. Clinical experience in children and adolescents under 15 years of age is limited. Body weight 50 kg or more: The initial dose is 0.5 mg of this medication once daily. If needed, depending on the patient, the dose may be increased by 0.5 mg per day at intervals of at least 2 days. The optimal dose for most patients is 1 mg once daily. Depending on the patient, 0.5∼1.5 mg may be administered once daily. Body weight less than 50 kg: The initial dose is 0.25 mg once daily. If needed, depending on the patient, the dose may be increased by 0.25 mg per day at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. Clinical experience in children under 5 years of age is limited.

This medication may increase mortality when used in elderly patients with dementia, so special caution is required. Careful consideration should be given to the combination of this medication with certain diuretics like furosemide, as it may increase the risk of death in elderly dementia patients. Before using this drug, the risk factors for venous thromboembolism, which is the risk of developing blood clots, should be well assessed, and appropriate preventive measures should be taken. This drug should not be administered to patients with allergies to this medication or its components, those in a severely depressed state of the central nervous system, those in a comatose state, or those receiving epinephrine treatment. Patients with certain hereditary metabolic disorders, such as lactose intolerance, should also not take this medication. Patients with heart-related diseases or hepatic and renal functional disorders should adjust the dose when using this medication and be monitored closely. Special caution is needed for individuals with a history of suicide attempts, those with Parkinson's disease or Lewy body dementia, diabetes patients, elderly individuals, pregnant women, and nursing mothers regarding the use of this drug. Various side effects may occur, including drowsiness, dizziness, orthostatic hypotension, gastrointestinal symptoms, skin rashes, and muscle abnormalities. Regular monitoring is required during treatment as weight gain, fluctuations in blood sugar, and worsening of psychiatric symptoms may also be observed. When taken with other central nervous system depressants or alcohol, the central nervous system depressant effects may be enhanced, and caution should be exercised. Since this drug is metabolized in the liver, drug concentrations may change when taken with medications that inhibit or induce specific liver metabolic enzymes, necessitating dose adjustments. Women who are pregnant or nursing should carefully consider the potential effects on the fetus or newborn when using this medication and are recommended to discontinue breastfeeding. In case of overdose, seek medical attention immediately and provide appropriate emergency care, as there is no specific antidote for this drug, making supportive treatment important based on symptoms. Keep this medication out of the reach of children and avoid transferring it to other containers.

Coinfection, upper respiratory tract infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, neuroexcitability, Parkinson's disease, inability to sit still, drowsiness, dizziness, sedation, tremor, abnormal muscle tone, hypersomnolence, orthostatic dizziness, dyskinesia, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleed, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, upper abdominal pain, rash, dry skin, dandruff, seborrheic dermatitis, keratosis, back pain, joint pain, limb pain, urinary incontinence, erectile dysfunction, fatigue, weakness, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, urinary tract infection, pneumonia, soft tissue infection, decreased appetite, confused state, hypersomnolence, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, difficulty swallowing, fecal lump, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, upper respiratory tract infection, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, excessive sleep, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequency of urination, galactorrhea, emotional disturbance, apathy, chest discomfort, agitation, blunted affect, sleep disorder, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperation abnormality, loss of consciousness, speech disorder, sensory loss, motor disorder, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory abnormalities, conjunctival injection, ocular discharge, eye movement, eyelid swelling, photophobia, crusting of eyelid margins, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, dizziness, bradycardia, tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disorder, abnormal electrocardiogram, prolonged QT interval, venous return, bradycardia, wheezing, aspiration pneumonia, voice impairment, wet cough, airway congestion, rales, respiratory disorder, nasal congestion, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, distension, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, dermatological disorders, erythematous rash, papular rash, systemic rash, papulovesicular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urination disorder, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorder, breast engorgement, sexual dysfunction, retrograde ejaculation, breast secretion, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, weight gain, elevated blood prolactin, agranulocytosis, thrombocytopenia, anaphylactic reaction, antidiuretic hormone secretion abnormality, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, elevated blood cholesterol, elevated blood triglycerides, mania, taste disorder, intraoperative iris hypotonia syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, persistent erection, hypothermia, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorder, leukopenia, arrhythmia, nosebleed, anemia, diarrhea, hangover, ocular movement seizures, acne, difficulty swallowing, enuresis, tic disorder, dyspnea, Rabbit syndrome, suicidal thoughts, thought disorder, delusion, hallucination, exacerbation of auditory hallucinations

Store this medication in a tightly sealed container to prevent exposure to air or moisture, and it is best kept at room temperature between 1°C and 30°C. Proper storage will help maintain the drug’s effectiveness and prevent degradation.

Appearance

Oblong white film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle